Rail catheter ablation and mapping system

ABSTRACT

An ablation system for ablating cardiac tissue within a chamber of the human heart including a guiding introducer system, a rail, one end of which is contained within the guiding introducer system, and an ablation catheter system which is supported by the guiding introducer system. The guiding introducer system may be a single or multiple guiding introducers. The ablation system may include a slotted sheath which passes over the rail which supports the ablation catheter. A process is disclosed for ablation of cardiac tissue to form a linear lesion utilizing a rail catheter ablation and mapping system which includes a guiding introducer, a rail and an ablation catheter system advanced over the rail.

FIELD OF INVENTION

This invention relates to a rail catheter ablation and mapping systemdesigned to map and ablate specific locations within chambers of a humanheart. In addition, it relates to a process for mapping and ablatingcardiac tissue utilizing a rail catheter ablation and mapping system toform linear lesions within chambers of a human heart.

BACKGROUND

Catheters have been in use for medical procedures for many years.Catheters can be used for medical procedures to examine, diagnose andtreat while positioned at a specific location within the body which isotherwise inaccessible without more invasive procedures. During theseprocedures a catheter is inserted into a vessel located near the surfaceof a human body and is guided to a specific location within the body forexamination, diagnosis and treatment. For example, one procedureutilizes a catheter to convey an electrical stimulus to a selectedlocation within the human body. Another procedure utilizes a catheterwith sensing electrodes to monitor various forms of electrical activityin the human body.

Catheters are used increasingly for medical procedures involving thehuman heart. Typically, the catheter is inserted in an artery or vein inthe leg, neck or arm of the patient and threaded, sometimes with the aidof a guidewire or introducer, through the vessels until a distal tip ofthe catheter reaches the desired location for the medical procedure inthe heart.

A typical human heart includes a right ventricle, a right atrium, a leftventricle and a left atrium. The right atrium is in fluid communicationwith the superior vena cava and the inferior vena cava. Theatrioventricular septum separates the right atrium from the rightventricle. The tricuspid valve contained within the atrioventricularseptum provides communication between the right atrium and the rightventricle. On the inner wall of the right atrium, where it is connectedwith the left atrium, is a thin-walled, recessed portion, the fossaovalis. Medical procedures are frequently performed in the left atriumusing transseptal procedures performed through the interatrial septum.Present in the wall of the left atrium are the entrances to the fourpulmonary veins: the right superior, the left superior, right inferiorand left inferior pulmonary veins. The mitral valve contained in theatrioventricular septum provides communication between the left atriumand the left ventricle.

In the normal heart, contraction and relaxation of the heart muscle(myocardium) takes place in an organized fashion as electro-chemicalsignals pass sequentially through the myocardium from the sinoatrial(SA) node to the atrioventricular (AV) node and then along a welldefined route which includes the His-Purkinje system into the left andright ventricles.

Sometimes abnormal rhythms occur in the heart which are referred togenerally as arrhythmia. Abnormal arrhythmias which occur in the atriaare referred to as atrial arrhythmia. Three of the most common atrialarrhythmia are ectopic atrial tachycardia, atrial fibrillation andatrial flutter. Atrial fibrillation is the most common of all sustainedcardiac arrhythmias. While it is present in less than one percent of thegeneral population, it has been estimated that at least 10 percent ofthe population over 60 is subject to atrial fibrillation. Althoughfrequently considered to be an innocuous arrhythmia, atrial fibrillationcan result in significant patient discomfort and even death because of anumber of associated problems, including: an irregular heart rate whichcauses patient discomfort and anxiety, loss of synchronousatrioventricular contractions which compromises cardiac hemodynamicsresulting in varying levels of congestive heart failure, and stasis ofblood flow, which increases the likelihood of thromboembolism.

Efforts to alleviate these problems in the past have includedsignificant usage of pharmacological treatments. While pharmacologicaltreatments are sometimes effective, in some circumstances drug therapyhas had only limited effectiveness and is frequently plagued with sideeffects, such as dizziness, nausea, vision problems and otherdifficulties.

An increasingly common medical procedure for the treatment of certaintypes of cardiac arrhythmia is catheter ablation. The use of cathetersfor ablating specific locations within the heart has been disclosed, forexample in U.S. Pat. Nos. 4,641,649, 5,263,493, 5,231,995, 5,228,442 and5,281,217.

The use of RF energy with an ablation catheter contained within atransseptal sheath for the treatment of W-P-W in the left atrium isdisclosed in Swartz, J. F. et al. "Radiofrequency Endocardial CatheterAblation of Accessory Atrioventricular Pathway Atrial Insertion Sites"Circulation Vol. 87, pgs. 487-499 (1993).

Ablation of a specific location within the heart requires the preciseplacement of the ablation catheter within the heart. One procedure usedto place ablation catheters at a specific location in the heart utilizesa guiding introducer or a pair of guiding introducers. Ablationprocedures using guiding introducers for treatment of atrial arrhythmiahave been disclosed in U.S. Pat. Nos. 5,497,774, 5,427,119, 5,575,166,5,640,955, 5,564,440 and 5,628,316. Lesions are produced in the hearttissue as an element of these procedures.

Placement of catheters at particular locations in a human body issometimes accomplished using guide wires. For example, U.S. Pat. No.5,163,911 discloses a catheter system utilizing a guidewire to guide aworking catheter within the vasculature to perform medical procedures.U.S. Pat. No. 5,209,730 discloses an over-the-wire balloon dilationcatheter for use within a vessel of the heart. A similar extendableballoon on a wire catheter system is disclosed in U.S. Pat. No.5,338,301.

A different type of ablation catheter is disclosed in U.S. Pat. No.5,482,037, which discloses an electrode catheter for insertion into acavity of the heart. U.S. Pat. Nos. 5,487,385 and 5,575,810 discloseablation systems which are utilized for mapping and ablation procedureswithin the right atria of the heart.

Conventional ablation procedures utilize a single distal electrodesecured to the tip of an ablation catheter. Increasingly, however,cardiac ablation procedures utilize multiple electrodes affixed to thecatheter body.

The ablation catheters commonly used to perform these ablationprocedures produce scar tissue at particular points in the cardiactissue by physical contact of the cardiac tissue with an electrode ofthe ablation catheter. One difficulty in obtaining an adequate ablationlesion using conventional ablation catheters is the constant movement ofthe heart, especially when there is an erratic or irregular heart beat.Another difficulty in obtaining an adequate ablation lesion is caused bythe inability of conventional catheters to obtain and retain uniformcontact with the cardiac tissue across the entire length of the ablationelectrode surface. Without such continuous and uniform contact, anyablation lesions formed may not be adequate.

Effective ablation procedures are sometimes quite difficult because ofthe need for an extended linear lesion, sometimes as long as about 3inches to 5 inches (approximately 8 cm. to 12 cm.). To produce such alinear lesion of this length within an erratically beating heart is adifficult task.

One process for the production of linear lesions in the heart by use ofan ablation catheter is disclosed in U.S. Pat. Nos. 5,487,385, 5,582,609and 5,676,662. In addition, a process for the production of a series oflinear lesions in the atria for the treatment of atrial arrhythmia isdisclosed in U.S. Pat. No. 5,575,766.

To form linear lesions within the heart using a conventional ablationtip electrode requires the utilization of procedures such as a "dragburn". During this procedure, while ablating energy is supplied to theablating electrode, the ablating electrode is drawn across the tissue tobe ablated, producing a line of ablation. Alternatively, a series ofpoints of ablation are formed in a line created by moving the ablatingelectrode incremental distances across the cardiac tissue. Theeffectiveness of these procedures depends on a number of variablesincluding the position and contact pressure of the ablating electrode ofthe ablation catheter against the cardiac tissue, the time that theablating electrode of the ablation catheter is placed against thetissue, the amount of coagulum that is generated as a result of heatgenerated during the ablation procedure and other variables associatedwith a beating heart, especially an erratically beating heart. Unless anuninterrupted track of ablated cardiac tissue is created, unablatedcardiac tissue or incompletely ablated cardiac tissue may remainelectrically active, permitting the continuation of the reentry circuitwhich causes the arrhythmia. Thus, new devices are necessary for theproduction of linear lesions in the heart.

SUMMARY OF INVENTION

The present invention is a rail catheter ablation and mapping system forablation procedures in the human heart which, in a preferred embodiment,includes an inner and an outer guiding introducer, a rail, an ablationcatheter, and a slotted sheath. One end of the rail is secured to theouter guiding introducer. The rail is advanced out of the guidingintroducers. The ablation catheter is extended through a lumen of theslotted sheath. The slotted sheath with ablation catheter inside isextended from the guiding introducers over the rail to form a loop tomap and ablate cardiac tissue.

Also disclosed is a rail caetheter ablation and mapping system whichincludes a single guiding introducer, a rail, a slotted sheath, and anablation catheter. One end of the rail is secured to the guidingintroducer. The rail is advanced out of the guiding introducer. Theablation catheter is extended through a lumen of the slotted sheath. Theslotted sheath with ablation catheter inside is extended from theguiding introducer over the rail to form a loop to map and ablatecardiac tissue.

The ablation procedures may be performed by use of an ablation cathetercontaining a single electrode which may be formed from a series ofcoils. As an alternative, the ablation catheter includes a series ofelectrodes. Either of these ablation catheters preferably performs theablation procedure through slots of the slotted sheath with a flushingsystem utilized within the slotted sheath and/or within the ablationcatheter to cool and flush the electrode during the ablation procedure.

Also disclosed is a rail catheter ablation and mapping system whichincludes a guiding introducer system, a rail, and an ablation catheterwhich includes one or more electrodes contained in a lumen of theablation catheter. A plurality of openings are provided in the surfaceof the ablation catheter. A system for introduction of a conductivemedia through the lumen of the ablation catheter is also provided whichpasses the conductive media through the openings to conduct the ablatingenergy to the tissue to be ablated.

Also disclosed is a rail catheter ablation and mapping system whichincludes a guiding introducer system, a rail and an ablation catheterwith flexible electrodes.

A process for ablation of cardiac tissue to form linear lesions in achamber of a human heart is also disclosed. During the procedure, aguiding introducer system, with a rail secured to the guidingintroducer, is advanced through the vasculature of the human body intothe chamber of the heart. The rail is extended from the guidingintroducer. A slotted sheath is then extended through a lumen of theguiding introducer over the rail. The ablation catheter passes through alumen in the slotted sheath. As the slotted sheath containing anablation catheter passes over the surface of the cardiac tissue, it mapsand/or ablates the cardiac tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a cutaway view of a human heart showing the rail catheterablation and mapping system in use about an inner surface of the leftatrium.

FIG. 2 is a perspective view of the first embodiment of the railcatheter ablation and mapping system containing an inner and outerguiding introducer and a slotted sheath with the ablation catheterextending from the distal tip of the inner guiding introducer.

FIG. 3 is a perspective, exploded view of an ablation catheter with tipelectrode utilized with the slotted sheath of the rail catheter ablationand mapping system of FIG. 2.

FIG. 4 is a perspective view of a second embodiment of the rail catheterablation and mapping system showing an inner and outer guidingintroducer and an ablation catheter extending from the distal tip of theinner guiding introducer.

FIG. 5 is a perspective view of the ablation catheter of the railcatheter ablation and mapping system of FIG. 4.

FIG. 6 is a side cutaway view of the ablation catheter of FIG. 5.

FIG. 7 is a perspective view of a third embodiment of the rail catheterablation and mapping system containing an inner and outer guidingintroducer, a rail, and an ablation catheter containing a plurality ofelectrodes, which catheter extends from the distal tip of the innerguiding introducer.

FIG. 8 is a perspective view of a fourth embodiment of the rail catheterablation and mapping system disclosing a single guiding introducer, anablation catheter extending from the distal tip of the guidingintroducer, and a rail.

FIG. 9 is a cutaway side view of the outer guiding introducer and railof the rail catheter ablation and mapping system of FIG. 2, with therail secured near the proximal end of the outer guiding introducer.

FIG. 10 is a perspective view of an ablation catheter of the railcatheter ablation and mapping system of FIG. 7 containing multipleelectrodes.

FIG. 11 is a side cutaway view of a portion of the slotted sheath andablation catheter of the rail catheter ablation and mapping system ofFIG. 2 which contains the ablation catheter with coiled electrode and aportion of the rail.

FIG. 12A is a cross-section of a proximal portion of the ablationcatheter of FIG. 6 showing a pair of lumens.

FIG. 12B is a cross-section of a distal portion of the ablation catheterof FIG. 6 showing a pair of lumens, one containing the rail and thesecond containing the electrode of the ablation catheter.

FIG. 13 is a perspective view of the inner and outer guiding introducerof FIG. 2 with the rail and dilator positioned for vascularintroduction.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

The rail catheter ablation and mapping system (10) of the presentinvention as shown in FIGS. 1 and 2 includes a guiding introducer system(11), comprising preferably an inner guiding introducer (12) and anouter guiding introducer (14), each with proximal and distal ends andeach containing a lumen (13, 15) extending lengthwise substantiallythrough each of the guiding introducers, a rail (16), and an ablationsystem (18) passing through the lumen (13) of the inner guidingintroducer (12). In the first embodiment of the invention, as shown inFIGS. 3 and 11, the ablation system (18) consists of an ablationcatheter (20) passing through a lumen (33) of a slotted sheath (22).

In a second embodiment of the present invention, as shown in FIGS. 4, 5and 6, the rail catheter ablation and mapping system (100) includes aguiding introducer system (102), which is preferably an inner guidingintroducer (104) and an outer guiding introducer (106), a rail (108),and an ablation catheter (110) containing at least two lumens (112,114). The ablation catheter (110) includes a plurality of openings (116)through the surface (122) of the ablation catheter (110), an electrode(118) contained within one of the lumen (114) of the ablation catheter(110) and a system (not shown) for introduction of a conductive mediainto one of the lumen (114) of the ablation catheter (110).

In a third alternative embodiment, as shown in FIGS. 7 and 10, the railcatheter ablation and mapping system (200) includes a guiding introducersystem (202), which is preferably an inner guiding introducer (204) andouter guiding introducer (206), a rail (208), and an ablation catheter(210) which passes over rail (208).

In a fourth alternative embodiment shown in FIG. 8, the rail catheterablation and mapping system (300) includes a single guiding introducer(302), a rail (304), and an ablation catheter system (306) which passesover the rail (304).

The introducer or introducers utilized with the rail catheter systems ofthe present invention can be any conventional guiding introducer with asufficient inner diameter to accommodate the rail catheter ablationsystem and introduce the ablation system into a chamber of the humanheart in which the ablation procedure is to be performed, preferably theleft atrium (17), as shown in FIG. 1. In a preferred embodiment, theintroducers are precurved inner and outer guiding introducers, such asthose sold by Daig Corporation under the names AMAS 1-2 outer and AMAS3-4 inner.

Medical practitioners normally monitor the introduction of a catheterand its progress through the vascular system by fluoroscope. However,such fluoroscopes do not easily identify the specific features of theheart in general and the particular structures of individual chambers ofthe human heart in specific, thus making placement of the rail catheterablation and mapping systems (10, 100, 200, 300) within the heartdifficult. Placement is also complicated when the heart is beatingresulting in the ablation system (18, 110, 210) moving within thechamber as blood is pumped through the heart throughout the procedure.Utilization of preferably a precurved inner guiding introducer andprecurved outer guiding introducer, with the rail catheter ablationsystems (18, 110, 210) makes placement of the ablation system at thecorrect location in the heart is made easier. In addition, use of therail catheter ablation and mapping systems (10, 100, 200, 300) resultsin more positive tissue contact which permits the formation of betterablation lesions.

In a preferred embodiment, as shown in FIGS. 1 and 2, an inner and outerguiding introducer (12, 14) are used in combination. When using an inner(12) and outer (14) guiding introducer, the outer diameter of the innerguiding introducer (12) is generally only slightly smaller than theinner diameter of the outer guiding introducer (14) so that the twointroducers can be used together. In a preferred embodiment, the rail(16) passes between the inner (12) and outer (14) guiding introducers.Thus, the difference in diameter between the inner diameter of the outerguiding introducer (14) and the outer diameter of the inner guidingintroducer (12) must be sufficient to accommodate the rail (16) withoutinterfering with the operation of the guiding introducer system (11). Ina preferred embodiment, the difference in diameter should be between 1and 3 French (one French unit equals 1/3 of a millimeter), about 0.01inch to about 0.04 inch (about 0.3 mm. to about 1 mm.).

By utilizing different curvatures for the distal portions (62) of theinner (12) and outer (14) guiding introducer and by rotating andextending the inner guiding introducer (12) in relation to the outerguiding introducer (14), the overall shape of the guiding introducersystem (11) can be modified to support the ablation system (18). Notonly can the use of a pair of guiding introducers (12, 14) incombination provide varying overall shapes for the guiding introducersystem (11) than when using a single guiding introducer, but the use ofa pair of guiding introducers (12, 14) is also helpful in the operationof the rail (16), as will be discussed in more detail. When a pair ofintroducers (12, 14) are utilized, in one preferred embodiment when theablation procedure is performed transseptally in the left atrium, thepreferred inner (12) and outer (14) guiding introducers are AMAS 1-2outer introducer and AMAS 3-4 inner introducer, produced by DaigCorporation.

In an alternative embodiment, instead of utilizing an inner (12) andouter (14) guiding introducer of the guiding introducer system (11), asingle precurved guiding introducer (302) can be utilized as an elementof the rail catheter ablation and mapping system (300), as shown in FIG.8.

The guiding introducers utilized with the guiding introducer systemcontain a first section (60) as shown in FIGS. 2 and 9 which isgenerally an elongated, hollow straight section of sufficient length forintroduction in the patient and for manipulation from the point ofinsertion to the specific desired location within the heart. Continuouswith the distal end of this first section of the guiding introducer is aprecurved, distal portion (62) of the guiding introducer as shown inFIGS. 2 and 9. The choice of curvature of this precurved distal portiondepends on the choice of location within the heart for the ablationprocedure. For example, when the ablation procedure occurs in the leftatrium using a transseptal approach, the preferred guiding introducersare AMAS guiding introducers manufactured by Daig Corporation. Theoverall curvature of the various guiding introducers can be modified byuse of various straight or curved sections to achieve the desired shapefor the guiding introducers. In addition, the choice of the guidingintroducer or guiding introducer system can be modified to place therail catheter ablation and mapping system (10, 100, 200, 300) at variouslocations within the chambers of the heart. Examples of acceptableguiding introducers are those disclosed, for example, in U.S. Pat. Nos.5,427,119, 5,497,774, 5,575,766, 5,640,955, 5,564,440, 5,628,316, and5,656,028, as well as other precurved guiding introducers sold by DaigCorporation.

An important design feature of the guiding introducer (302) or pair ofguiding introducers (12, 14) when used for an ablation procedure is thatthey provide a stable platform supported by the cardiac anatomy topermit the ablation system (18, 110, 210) and the rail (16) to beextended from the guiding introducer (302) or inner and outer guidingintroducers (12, 14) to circumscribe the inner surface of the chamber ofthe heart in which the medical procedure occurs. The guiding introducer(302) or pair of guiding introducers (12, 14) also provide stablesupport for the ablation system (18, 110, 210) to perform the ablationprocedure within the heart without the need for repeated repositioning.

The distal tip of the guiding introducers may be, and generally are,tapered to form a good transition with a dilator. The guidingintroducers may be made of any material suitable for use in humans,which has a memory or permits distortion from, and subsequentsubstantial return to, the desired three dimensional or complexmulti-planar shape. For purpose of illustration and not limitation, theinternal diameter of the guiding introducers may vary from about 6 toabout 14 French (about 0.07 inch to about 0.20 inch) (about 2.0 mm. toabout 5.0 mm.). Such guiding introducers can accept dilators from about6 to about 14 French (0.07 inch to about 0.20 inch) (about 2.0 mm. toabout 5.0 mm.) and appropriate guide wires. Obviously, if larger orsmaller dilators and catheters are used in conjunction with the guidingintroducers of the present invention, modification can be made in thesize of the guiding introducers.

The guiding introducer (12) preferably also contains one or a pluralityof radiopaque tip marker bands near the distal tip. Variousmodifications may be made in the shapes by increasing or decreasing thesize of the tip markers or adding additional tip markers.

The guiding introducer (12) also preferably contains one or a pluralityof vents (64, 214) near the distal tip of the guiding introducers,preferably 3 or 4 vents, as shown in FIGS. 2 and 7. The vents arepreferably located no more than about 2 to about 3 inches (about 5 cm.to about 8 cm.) from the distal tip of the guiding introducers and morepreferably about 0.1 inch to about 2.0 inches (about 0.2 cm. to about5.0 cm.) from the distal tip. The size of the vents should be in therange of about 0.02 inch to about 0.06 inch (about 0.05 cm. To about0.15 cm.) in diameter. The vents are generally designed to prevent airemboli from entering the guiding introducers due to the withdrawal of acatheter contained within the guiding introducers in the event thedistal tip of one of the guiding introducers is occluded.

Variances in size and shape of the guiding introducers are also intendedto encompass guiding introducers used with pediatric hearts. Whilepediatric ablation procedures are generally not performed on childrenless than about 2 years of age, under extreme situations, such ablationprocedures may be conducted. These procedures may require reductions inthe size and shape of the guiding introducers.

The configuration of the rail (16) is an important aspect of theinvention. The purpose of the rail (16) is to provide a guide andsupport for the ablation system (18, 110, 210) while the ablation and/ormapping procedures are being performed within the chamber of the heart.To provide this support, the rail (16) must be flexible enough not toinjure the inner surface of the chamber of the heart in which it isused, while still retaining sufficient structural integrity to supportthe ablation system (18, 110, 210) as it traverses around the innersurface of the chamber of the heart to perform the ablation procedure.

In order to achieve the preferred curvature and performance of the rail(16), in a preferred embodiment, the rail (16) is constructed of a superelastic metal alloy material, such as a nickel-titanium alloy, such as aNiTiNol® material. Such super elastic material is more preferably ashape memory alloy with a transformation temperature below that of thehuman body temperature. Alternatively, the shape memory alloy may alsohave a transformation temperature above that of the human body. In thisalternative utilization, an electric current is applied to the shapememory alloy material to convert it into a super elastic state. Whensuch super elastic, shape memory alloy is utilized, rail (16) retainsits curvature when exiting the outer guiding introducer (14) through theslot or opening (30) near the distal end (31) of the outer guidingintroducer (14), as shown in FIGS. 2 and 9, while still retainingsufficient flexibility to support the ablation system (18, 110, 210) asit circumscribes the inner surface of the heart chamber in which theablation procedure is performed.

In a preferred embodiment, the cross section of the rail is preferablyrectangular in shape, as shown in FIG. 12B. The rail (16) preferably isabout 0.02 inch to about 0.04 inch (about 0.05 cm. to about 0.1 cm.) inwidth and from about 0.005 inch to about 0.02 inch (about 0.01 cm. toabout 0.05 cm.) in thickness. As the preferred rail (16) is a flattenedwire, it is resistant to bending laterally while still retainingsufficient flexibility to form a loop when extended away from the outerguiding introducer (14) by advancing the ablation system (18, 110, 210)over the rail (16). The rail (16) should be of sufficient length so thatit can be fully extended into the chamber of the heart to be ablated andback out the proximal end of the guiding introducer system (11), exitingat point (19) as shown in FIG. 2. Thus, it should be at least about 60inches (152 cm.) in length.

One end (24) of the rail (16) is preferably secured in place as shown inFIG. 9. The manner of securing end (24) of the rail (16) in place andthe location where the rail (16) is secured is not critical. In onepreferred embodiment, end (24) of the rail (16) is secured to the hub(28) at the proximal end (26) of the outer guiding introducer (14). End(24) of the rail (16) is secured in place by conventional means, such aswith adhesives. Alternatively, one end of the rail (16) may be securedby conventional securing methods to one of the guiding introducerswithin a distal portion of the guiding introducer (not shown). Inanother alternative embodiment (not shown), neither end of the rail issecured in place and both ends pass through a lumen or lumens of theguiding introducer(s) and/or ablation system (18, 110, 210) and exit atthe proximal end of the guiding introducer(s) and/or ablation system(18, 110, 210).

When end (24) of the rail (16) is secured in place at the proximal end(26) of the outer guiding introducer (14), as shown in FIG. 9, theremaining portion of the rail (16) extends through the lumen (15) of theouter guiding introducer (14) between the inside surface of the outerguiding introducer (14) and the outside surface of the inner guidingintroducer (12) to a location near the distal end (31) of the outerguiding introducer (14). The rail (16) then exits through an opening orslot (30) provided in the surface of the outer guiding introducer (14).In a preferred embodiment, the opening or slot (30) extends at leastabout 20 degrees, and preferably as much as 180 degrees, around thecircumference of the outer guiding introducer (14). Opening or slot (30)permits the rail (16) to be moved laterally in relation to the outerguiding introducer (14) to adjust the position of the ablation system(18, 110, 210) while in use in the heart.

In order to substantially circumscribe the inner surface of a chamber ofa human heart, the rail (16), preferably is angled outwardly from theouter guiding introducer (14) at an angle of approximately 60 to 180degrees and more preferably from about 80 to 100 degrees as it exits theouter guiding introducer (14) through the opening or slot (30) as shownin FIG. 9.

In a preferred embodiment, as shown in FIG. 9, the rail (16) extendsthrough the lumen (15) of the outer guiding introducer (14), out theopening or slot (30) and then loops back through a lumen (23) within theslotted sheath (22) as is shown in FIG. 11. However, the rail need notextend through the entire length of the slotted sheath (22) and may exitthrough the side of the slotted sheath (22) at a location (25) proximalfrom the distal end (40) of the slotted sheath (22). The rail then runsalong the side of the ablation catheter (18, 110, 210) through the lumen(13) of the inner guiding introducer (12) until it exits the proximalend of the inner guiding introducer (12).

The ablation catheters (18, 110, 210) is preferably a n elongatedcatheter made of materials suitable for use in humans, such asnonconductive polymers. Exemplary polymers used for the production ofthe catheter body include those well known in the art such aspolyurethanes, polyether-block amides, polyolefins, nylons,polytetrafluoroethylene, polyvinylidene fluoride, and fluorinatedethylene propylene polymers and other conventional materials.

The ablation catheters (18, 110, 210) preferably are flexible near itsdistal end (34) for at least 7 inches (18 cm.). While the more proximalportion of the ablation catheters (18, 110, 210) are preferably stifferthan the distal end, the stiffness of the ablation catheters (18, 110,210) may be consistent over their entire length. Enhanced stiffness isgenerally provided to the ablation catheters (18, 110, 210) byconventional catheter forming procedures, such as by braiding a portionof the ablation catheter (20), or by use of higher durometer cathetermaterials.

The ablation catheter (18, 110, 210 ) should be sufficiently flexible sothat its distal portion can pass smoothly through the lumen (33) withinthe slotted sheath (22) as shown in FIG. 11. However, the ablationcatheter (20) should also be sufficiently stiff so that it can beadvanced through the lumen (33) of the slotted sheath (22) without unduedifficulty.

The length of the ablation catheters (18, 110, 210) is preferably fromabout 20 to about 60 inches (about 50 cm. to about 150 cm.). Thediameter of the catheter is within ranges known in the industry,preferably, from about 4 to 16 French (about 0.05 inch to about 0.2inch) (about 1.3 mm to about 5.2 mm) and more preferably from about 6 to8 French (about 0.07 to about 0.1 inch) (about 1.8 mm to about 2.4 mm).

There are several alternative ablation systems. The ablation catheter(210) may contain a series of ring electrodes (37), as shown in FIG. 7,without a tip electrode. This ablation catheter (210) is introduced overthe rail (16) of the guiding introducer system (11), as shown in FIG. 7.Alternatively, the ablation system may consist of a conventionalablation catheter with a tip electrode (36) and a series of ringelectrodes (37).

The ring electrodes (37) may be rigid or flexible, circumferential ordirectional. The body of the ablation catheter (210) preferably containsone or more lumens extending through the catheter body from its proximalend to or near its distal end. Preferably, sufficient lumens are presentin the catheter body to accommodate wires for one or more sensing and/orablating electrodes. Thermosensing devices, such as thermocouples (notshown), may also be attached to the ablation catheter (20).

Alternatively a single tip electrode (46) may be used. The ablating tipelectrode (46) may be rounded and secured to the distal tip of theablation catheter (20) by conventional means.

The preferred source for energy generated through the ablatingelectrodes is radiofrequency energy, although other sources for energycan also be utilized including direct current, laser, ultrasound andmicrowave. The electrodes may monitor electrical activity within theheart.

In an alternative embodiment, the ablating electrode of the ablationcatheter may be a tip coil electrode (46) secured at or near the distaltip (34) of the ablation catheter (20), as shown in FIGS. 3 and 11. Thiscoil electrode (46) is preferably at least about 0.15 inch (0.4 cm.) inlength. It is preferably formed from wire coils with a cross-section ofabout 0.005 inch (0.013 cm.), which are secured to the outside surfaceof the ablation catheter (20) by conventional methods, such asadhesives. In order to cool the coil electrode (46) during use, coolingfluid is introduced through the lumen (33) of the slotted sheath (22)and the lumen (39) of the ablation catheter so that the fluid can flowaround and through the coils of the coil electrode (46) while theablation procedure is proceeding.

In a preferred embodiment, the ablation catheter (20) is advanced andwithdrawn within lumen (33) of the slotted sheath (22) as shown in FIG.11. The preferred slotted sheath (22) of the present invention isdisclosed in application Ser. No. 08/757,832, filed Nov. 27, 1996, ownedby the common assignee, which disclosure is incorporated herein byreference. Once the slotted sheath (22) is properly positioned over therail (16) in the cardiac chamber as shown in FIG. 1, the ablationcatheter (20) is advanced within the lumen (33) of the slotted sheath(22) to ablate the cardiac tissue to form an ablation track or lesion.

Openings (38) are provided in the body (27) of the slotted sheath (22)to form a longitudinal line extending from near the distal tip (40) ofthe slotted sheath (22) proximally as shown in FIGS. 3 and 11. Thenumber of individual openings (38) provided in the body (27) of theslotted sheath (22) is at least 3. The overall length of the flexibleportion of the body (27) of the slotted sheath (22) containing theopenings (38) is generally about the same length as the desired linearlesion to be formed, preferably from about 3 inches to about 5 inches(approximately 8 cm. to about 12 cm.).

The openings (38) in the body (27) of the slotted sheath (22) arepreferably from about 0.010 inch to about 0.050 inch (about 0.025 cm. toabout 0.127 cm.) in diameter. The shape of the openings (38) is notcritical, but preferably, they are longer than they are wide. Referringto FIG. 11, a bridge (42) of sheath material exists between individualopenings (38). The width of the bridge (42) of material should not begreater than about 0.05 inch (approximately 0.2 cm.). Located at thedistal tip (40) of the slotted sheath (22) is the opening (44) throughwhich the rail (16) extends through the slotted sheath (22). Thestructure of the slotted sheath (22) should be sufficiently flexible sothat it can circumscribe the inner surface of the chamber of the heart,as shown in FIG. 1, yet stiff enough to support the ablation catheter(20) and rail (16) contained within lumens (33, 23) of the slottedsheath (22).

In an alternative preferred embodiment, instead of using an ablationcatheter (20) advanced within a slotted sheath (22), the rail catheterablation and mapping system (100) may utilize an ablation catheter (110)such as is disclosed in application Ser. No. 08/897,300, filed Jul. 21,1997, owned by the common assignee and incorporated herein by reference,as shown in FIG. 6. The ablation catheter (110) of this system (100)contains a plurality of lumens (112, 114), one lumen (112) of which isused to receive the rail (16) as shown in FIGS. 12A and 12B. One or moreelectrodes (118) are located within a lumen (114) of the ablationcatheter (110). A series of openings (116) are provided in the outersurface (122) of the ablation catheter (110), which extend from theouter surface (122) into the lumen (114) containing the electrodes(118). A system (not shown) is provided for the introduction of aconductive media into the lumen (114), which media conductively contactsthe electrode (118) and then passes out through the openings (116) inthe surface (122) of the ablation catheter (110). The electrode (118)utilized in one preferred embodiment, as shown in FIG. 6, constitutesone or more coiled electrodes extending along the length of the lumen(114) inside the ablation catheter (110). The conductive media is forcedout of the openings (116) in the ablation catheter (110). The electrode(118) does not directly contact the cardiac tissue to be ablated.Instead, the conductive media conducts the energy, preferablyradiofrequency energy, from the electrode (118) to the surface of thecardiac tissue to be ablated. As the impedance of the conductive mediais maintained at a level less than that of the impedance of the cardiactissue, the cardiac tissue will heat up as the ablation procedureproceeds. If sufficient energy is conducted to the tissue by theconductive media for a sufficient period of time, a satisfactoryablation lesion will be formed.

In order to produce an adequate lesion, the flow of the conductive mediashould occur through all or substantially all of the openings (116)along the length of the ablation catheter (110). Any structural systemwhich controls the flow of the conductive media through these openings(116) is consistent with this invention. Several such systems aredisclosed in application Ser. No. 08/897,300, filed Jul. 21, 1997, whichdisclosure is incorporated into this application by reference.

Instead of utilizing a coiled electrode (118), as shown in FIG. 6, otherelectrode systems can be utilized, including a coated tubular body, aconductive filter element, and the utilization of a chemical ablativeelement. Each of these systems is disclosed in application Ser. No.08/897,300, filed Jul. 21, 1997, which systems are incorporated byreference into this application.

FIG. 7 discloses another alternative rail catheter ablation and mappingsystem (200). This system (200) includes a guiding introducer system(11), which is preferably an inner guiding introducer (12) and an outerguiding introducer (14), an ablation catheter (210) and a rail (16). Theinner (12) and outer (14) guiding introducers and the rail (16) aresimilar to those previously discussed. The ablation catheter (210) mayhave a plurality of electrodes (37). However, no slotted sheath isutilized with this embodiment. The ablation catheter (210) is firstextended over the rail (16) to isolate the cardiac tissue from the rail(16). Flushing may be provided through catheter (210) to flow out andaround the electrodes (37) for cooling during ablation. In thisembodiment, the rail (208) with catheter (210) is then extended from theguiding introducers (12, 14) to circumscribe the chamber of the heart.

In operation, a modified Seldinger technique for inserting hemostasisintroducers for vascular access is normally used for the insertion ofthe associated dilators and hemostasis introducers into the body. Theappropriate vessel is accessed by needle puncture. The soft flexible tipof an appropriately sized guidewire is inserted through and a shortdistance beyond the needle into the vessel. Firmly holding the guidewirein place, the needle is removed. A hemostasis introducer with a dilatoris then inserted into the vessel over the guidewire. A long guidewire isthen inserted into the vessel through the hemostasis introducer andadvanced into the right atrium. A transseptal introducer is thenadvanced into the right atrium through the hemostasis introducer andover the guidewire. A conventional transseptal technique is used forapproach into the left atrium of the heart. The guidewire is used toprovide a path from the left atrium transseptally back through thehemostasis valve after the transseptal technique has been performed.

The system (11), as assembled in FIG. 13, is then introduced over theguidewire. With the guidewire in place, a dilator (50) is advanced overthe guidewire within the appropriate inner (12) and outer (14) guidingintroducers. The rail (16) exits through the opening (30) in the outerguiding introducer (14) and loops around through an opening (48) in thedilator (50). The rail (16) then extends down the length of the dilator(50) and out its proximal end (52). The dilator (50), inner (12) andouter (14) guiding introducers and rail (16) form an assembly to beadvanced together over the guidewire into the appropriate chamber of theheart. After insertion of the assembly into the appropriate chamber ofthe heart, the guidewire is withdrawn. Once the dilator (50), inner (12)and outer (14) guiding introducers, and rail (16) are in position in theappropriate chamber of the heart, the inner guiding introducer (12) isrotated 180 degrees and the dilator (50) is withdrawn. The slottedsheath (22) of the ablation system (18) is then advanced over the rail(16) into the inner guiding introducer (12). The catheter ablationsystem (18) is advanced over the rail (16) through the distal tip (29)of the inner guiding introducer (12) until the distal tip (40) of theslotted sheath (22) approaches the opening or slot (30) in the outsidesurface of the side of the outer guiding introducer (14), as shown inFIGS. 1 and 2. The ablation catheter system (18) is then advanced out ofthe distal end (29) of the inner guiding introducer (12) such that itcontacts the wall of the heart. The distal tip (29) of the inner guidingintroducer (12) is advanced away from the distal tip (31) of the outerguiding introducer (14), as shown in FIG. 1, until the distal tip (29)of the inner guiding introducer (12) approaches the opposite side of thechamber of the heart in which the ablation procedure is to be performed.The distal tip (31) of the outer guiding introducer (14) is retained ator near the opening into the chamber of the heart. By this process, aloop of the slotted sheath (22) over the rail (16) can be formed thatcircumscribes the entire surface of the chamber of the heart as shown inFIG. 1. The specific placement of the ablation system (18) on thesurface of the chamber of the heart can be adjusted by rotating,advancing or withdrawing the inner guiding introducer (12) in relationto the outer guiding introducer (14).

After the desired location for ablation is determined, the ablationcatheter (20) is positioned within the slotted sheath (22). In apreferred embodiment, as the ablation catheter (20) is advanced, itfirst senses the electrical activity of that chamber of the heart alongthe pathway created by the rail (16) located within the slotted sheath(22). Once the proper location for the ablation procedure is determined,the ablation catheter (20) utilizing energy, preferably radiofrequencyenergy, performs the ablation procedure in the heart and forms a linearlesion by dragging the ablation catheter (20) through the slotted sheath(22). For the catheters (110, 210) the procedure for use is the same asthe procedures using the slotted sheath(22). Because of the rail (16),the slotted sheath system (18) or the ablation catheter (110, 210) canmaintain tissue contact in the cardiac chamber throughout the ablationprocedure, making the formation of linear lesions significantly easier.Thermosensing devices, such as thermocouples, may also be secured to theablation catheter to determine whether sufficient energy has beenapplied to the tissue to create an adequate linear lesion.

Alternatively, an ablation catheter can be advanced over the rail (16)to create a linear lesion, such that the rail (16) is in direct contractwith the tissue. The rail (16) in this embodiment provides a lineartrack for the catheter (110, 210) to slide over.

After the ablation procedure is completed, a sensing electrode may beused to determine if the arrhythmia has been eliminated at theparticular location within the heart. Additional ablation lesions ortracks may then be produced, if necessary, using the ablation catheter(18, 110, 210) at the same or different locations within the heart.

Pharmacological treatments may also be used in combination with ablationprocedures to relieve the atrial arrhythmia.

This rail catheter ablation and mapping system (10, 100, 200, 300)provides several improvements over conventional ablation systems,including steerable catheters. This rail catheter ablation and mappingsystem (10, 100, 200, 300) allows ablation catheters to maintainpositive contact with the cardiac tissue to be ablated to form linearlesions that are contiguous and continuous. These systems also allow theablation catheter system (18, 110, 210) to be firmly placed against thetissue to be ablated. When used with a guiding introducer system,preferably an inner and outer guiding introducer, a stable platform forthe rail and ablation system (18, 110, 210) is created to maintainpositive contact with the cardiac tissue to be ablated. The railcatheter ablation and mapping system (10, 100, 200, 300) also permits asingle positioning of the ablation catheter for the creation of a linearablation lesion without the need for continuous repositioning of theablation catheter. Because the rail is preferably rectangular in shape,it is flexible to conform to the contours of the cardiac tissue to beablated while still maintaining lateral stiffness to retain the railcatheter ablation and mapping system (10, 100, 200, 300) at the correctlocation for formation of the linear lesions. The use of a flushingsystem around the rail and the electrodes prevents formation of coagulumduring the ablation procedure.

It will be apparent from the foregoing that while particular forms ofthe invention have been illustrated and described, various modificationscan be made without departing from the spirit and scope of theinvention.

We claim:
 1. A rail catheter ablation and mapping system for ablationprocedures in a chamber of a human heart, comprising;a guidingintroducer containing a lumen, whereing the lumen includes an opening ina distal end of the guiding introducer and wherein the guidingintroducer contains a slot passing through the guiding introducer, whichslot is located proximal from the distal end of the guiding introducer,an extendable rail, one end of which is contained within the guidingintroducer, wherein the rail is extended through the slot in the guidingintroducer and reenters the guiding introducer through the opening inthe distal end of the guiding introducer, and an ablation cathetercontaining a lumen, wherein the catheter passes within the lumen of theguiding introducer, and wherein the ablation catheter passes over therail.
 2. The rail catheter ablation and mapping system of claim 2wherein the rail extends outwardly through the slot of the guidingintroducer at an angle of about 60 to about 180 degrees.
 3. The railcatheter ablation and mapping system of claim 2 wherein the rail has agenerally rectangular cross-section.
 4. The rail catheter ablation andmapping system of claim 2 wherein one end of the rail is secured to theguiding introducer.
 5. The rail catheter ablation and mapping system ofclaim 2 wherein the rail is comprised of a superelastic, shaped memoryalloy.
 6. The rail catheter ablation and mapping system of claim 2wherein the ablation catheter further comprises a series of ringelectrodes.
 7. The rail catheter ablation and mapping system of claim 6further comprising a system for introducing a cooling fluid through theablation catheter.
 8. The rail catheter ablation and mapping system ofclaim 2 wherein the ablation catheter comprises a plurality of lumens,an electrode contained within one of those lumens and a series ofopenings in an outer surface of the ablation catheter communicatingbetween the outer surface of the ablation catheter and the electrode. 9.The rail catheter ablation and mapping system of claim 2 wherein theguiding introducer comprises a precurved distal portion.
 10. The railcatheter ablation and mapping system of claim 2 further comprising aflexible electrode secured to the ablation catheter.
 11. A procedure formapping and ablation of cardiac tissue comprisingpreparing a guidingintroducer containing a lumen, wherein the lumen includes an opening ina distal end of the guiding introducer and wherein the guidingintroducer contains a slot passing through the guiding introducer, whichslot is located proximal from the distal end of the guiding introducer,advancing an extendable rail through at least a portion of the guidingintroducer, wherein one end of the rail is contained within the guidingintroducer and wherein the rail is extended through the slot in theguiding introducer and reenters the guiding introducer through theopening in the distal end of the guiding introducer, advancing theguiding introducer and rail into a chamber of a heart for the mappingand ablating procedure, advancing an ablation catheter through a lumenof the guiding introducer into the chamber of the heart, and extendingthe ablation catheter over the rail inside of the chamber of the heartto map and ablate cardiac tissue.